Associate Director eClinical Business Capability Lead (Planning and Initiations Segment)

Job Description

New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.

The eClinical Business Capability Lead will work with the Head of eClinical Technologies, and other senior business capabilities lead(s) to develop and successfully execute the business strategy and technology innovations of Global Clinical Trial Operations (GCTO) business e-Capabilities of the assigned capability area. As such, it is critical that the individual is able to effectively and efficiently engage stakeholders both internal and external, working with leaders throughout the business in Research & Development, Information Technology, Quality, Regulatory and others in pursuit of clear and accurate enablement of eClinical technologies and innovation roadmap at scale focused on speed, flexibility, quality, and industrialization. Serve as a core member of the eClinical Technologies Leadership team, proactively engages with stakeholders inside and outside the functional area and across global sites to drive efforts critical to the success of GCTO more broadly. It is an entrepreneurial role requiring the creativity and attitude of a start-up and an urgency to drive change.

Responsibilities:

• Provide Subject matter expertise in the digital and its fit-for-purpose in the clinical development value chain to enable new capabilities of the assigned capability area.

• Collaborate with internal and external partners, including industry consortia, to champion and drive innovation, mediate conflict resolution, and encourage an organizational culture, which promotes behaviors that lead to meaningful synergies and superior business performance to create value through innovation where and when it matters most in the assigned capability area.

• Oversee chartering and build of high-impact & high-value business cases for innovation opportunities in collaboration with functional stakeholders, Head of product/solution delivery, IT, etc. to advance selected solutions from proof of concept to pilot and implementation at scale, ensuring that required due diligence has been carried out, and the solution is audit/inspection ready, if applicable.

• Drive user-centricity in approaches to developing a solution by embracing design thinking methodologies and collaborating with user experience experts.

• Monitor technology trends to match the Global Clinical Trial Operations' and company priorities and unmet needs, both domestic and abroad; profile partners and vendors and map capabilities to requirements that could enable step-change in the way we conduct clinical trials in alignment with the GCTO strategy.

• Ensure or Perform process impact assessments as needed to determine breadth and risks involved with proposed change initiatives.

• Partner with a cross-functional team of functional SMEs and end-users to independently assess new external opportunities.

• Manage the identified Key Performance Indicators (KPIs) to measure outcomes and success for implementing new clinical innovation opportunities to improve clinical operations productivity and site and patient experiences.

• Understand the clinical research environment with a track record of successfully initiating and driving complex projects to completion.

• Partner with the Head of Product/Solution Delivery to ensure effective project portfolio execution, including development and deployment of relevant change management interventions, successful introductions, implementations, and embedding of new and disruptive technologies and business processes.

• Having an enterprise mindset with a proven ability to partner cross-culturally and cross-functionally, to develop strong collaborations, and to inspire trust across the organization and at all levels is important.

• Establish a baseline for customer satisfaction, monitor customer satisfaction regularly through forums and surveys, and leverage the insights gained from customer feedback to refine the roadmap.

• Be comfortable exploring new spaces with little or no experience or existing guidelines to follow with minimal supervision.

• Represent the functional area/company as a Key Opinion Leader in international conferences, consortia's, cross-industry groups, and public-private forums.

• Facilitate proactive sharing of knowledge and key learnings within the group and across other functions.

• Coach and Mentor less experienced associates as required.

Minimum required education:

Bachelor's degree in Science, Engineering, Computer Science, Health Care, Maths, Medicines, Pharmacy related discipline.

Required experience:

Minimum 10 years of experience in the clinical domain with at least 8 years of experience in global clinical research within the Pharmaceuticals, Medical Devices, Biotech, CRO, or other clinical trial sponsor environment preferred.

Experience and Skills:

• Experience in a lead role executing/overseeing simple-moderate level projects or organizational improvement initiatives preferred.

• Understanding of drug development - safety, clinical trials, trial design, data management, trial operations, privacy, ICH, and GCP required.

• Proven track record in translating business strategies into clearly defined implementation roadmaps.

• Project Management experience is required.

• Demonstrated success in defining and executing high-impact technology and innovation road maps.

• Proven track record in leading mid-size cross-functional initiatives focusing on business benefit outcomes and faster business adoption.

• Must have strong networking and relationship-building skills.

• Demonstrates the courage to assume personal accountability in challenging situations

• Demonstrated unwillingness to accept the status quo.

• Must have excellent oral and written communications skills - able to present information confidentially and effectively to leadership, peers, and team.

• Ability to influence without authority and successfully manage various level stakeholders.

• Prior exposure to or demonstrated the use of design thinking methodologies is desirable.

#EligibleforERP
#MRLGCTO

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

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Requisition ID:R159247